MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERLOCK; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	83779
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that the coil broke from the wire and snaring occurred.The patient underwent a pulmonary artery embolization procedure where a 10mm x 50cm interlock was selected for treatment.The device was deployed as per instructions.During the procedure, the coil did not detach from the lock arm/portion and instead detached 10 to 12cm proximal to the designed lock arm and broke from the wire.The separated fragment was visible under the fluoroscopy and the physician used a snare wire to capture the coil material and retrieve it immediately.The coil was successfully removed, and the procedure was completed using a different device.There were no patient complications reported.
Event or Problem Description
It was reported that the coil broke from the wire and snaring occurred.The patient underwent a pulmonary artery embolization procedure where a 10mm x 50cm interlock was selected for treatment.The device was deployed as per instructions.During the procedure, the coil did not detach from the lock arm/portion and instead detached 10 to 12cm proximal to the designed lock arm and broke from the wire.The separated fragment was visible under the fluoroscopy and the physician used a snare wire to capture the coil material and retrieve it immediately.The coil was successfully removed, and the procedure was completed using a different device.There were no patient complications reported.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).G1 - mfr site zip/post code: (b)(4).Device eval by mfr: the device was not returned.However, a photo was provided from the healthcare facility and it is possible to observe the device in an x-ray procedure.Based on the evidence, the reported allegations could not be confirmed, due the reported error cannot be observed in a readable manner.
Event or Problem Description
It was reported that the coil broke from the wire and snaring occurred.The patient underwent a pulmonary artery embolization procedure where a 10mm x 50cm interlock was selected for treatment.The device was deployed as per instructions.During the procedure, the coil did not detach from the lock arm/portion and instead detached 10 to 12cm proximal to the designed lock arm and broke from the wire.The separated fragment was visible under the fluoroscopy and the physician used a snare wire to capture the coil material and retrieve it immediately.The coil was successfully removed, and the procedure was completed using a different device.There were no patient complications reported.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).G1 - mfr site zip/post code: t12 yk88.Device evaluated by mfr.: the device was returned for analysis.Visual and microscope inspections were performed and observed that the main coil was bent and stretched at the coil arm and the primary coil section.The arm coil was detached.The pusher wire was bent and stretched at the coil section.Dimensional inspection of the main coil was performed and revealed that they were within specification.There is a picture attached, and it is possible to observe the device in an x-ray procedure, however no is possible to determinate the reported code.No other issues were identified with the device.

• Brand Name: INTERLOCK
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19414817
• Report Number: 2124215-2024-32246
• Device Sequence Number: 8567111
• Product Code: KRD
• UDI-Device Identifier: 08714729845287
• UDI-Public: 08714729845287
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K132578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/16/2026
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0032225618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2024
• Supplement Date Received by Manufacturer: 06/06/2024; 04/30/2025
• Initial Report FDA Received Date: 05/29/2024
• Supplement Report FDA Received Date: 07/03/2024; 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 11 YR
• Patient Sex: Male